Experimental Medications: New S1P Receptor Modulators

HMG-CoA reductase inhibitors, commonly known as statins, long have been a mainstay of lipid control in the United States. One of these agents has shown promise in early clinical trials as a potential disease-modifying therapy for secondary-progressive MS (SPMS).

Results from the Phase II MS-STAT study in the United Kingdom suggest that simvastatin, which is available in the United States generically and under brand names such as Zocor and FloLipid, may slow disease and disability progression in SPMS. A total of 140 individuals with SPMS were randomized to receive simvastatin 80 mg daily (twice the recommended high-end dosage for lipid control) or placebo for two years. MRI scans performed at each patient visit showed slower rates of brain deterioration among individuals who received simvastatin compared with the placebo-treated group.80

Expanded Disability Status Scale (EDSS) scores, a common measurement of disability progression in MS, also increased more slowly among simvastatin-treated participants, compared with placebo. For anyone not familiar, the higher the EDSS score, the greater the severity of MS-related disability.80

The mechanism by which simvastatin exerts a therapeutic effect on MS is unclear. Researchers, however, believe that the medication’s actions in reducing “bad” cholesterol and preserving brain function in MS are independent of each other.80

Researchers hope to learn more about the potential role of simvastatin in treating SPMS from the upcoming Phase III MS-STAT2 clinical trial. An estimated 1,180 individuals with SPMS from throughout the United Kingdom and Ireland will be randomized to receive simvastatin 40 mg daily for one month followed by 80 mg for 35 months, or placebo. Participants’ physical and cognitive function will be tested every six months during the three-year study. Results are expected late summer 2023.81, 82